EP3592230A1

EP3592230A1 - Apparatus and method for imaging blood in a target region of tissue

Info

Publication number: EP3592230A1
Application number: EP18713138.8A
Authority: EP
Inventors: Scott Grubb; Allan Kenneth Frazer Grugeon HUNT; Peter Laitenberger
Original assignee: Smith and Nephew PLC
Current assignee: Smith and Nephew PLC
Priority date: 2017-03-09
Filing date: 2018-03-09
Publication date: 2020-01-15
Also published as: WO2018162732A1; US20200281513A1; US11324424B2; US20220330857A1

Abstract

In some embodiments, an apparatus for imaging blood within a target region of tissue includes an imaging device configured to output image data associated with light received by the imaging device having a first and second spectral ranges, wherein the absorptivity by blood of light having the first spectral range is less than the absorptivity by blood of light having the second spectral range, and a controlling element configured to capture the image data associated with light received by the imaging device and to process the captured image data associated with light having the first spectral range and the captured image data associated with light having the second spectral range to generate compound image data associated with an amount of blood within the target region of tissue.

Description

APPARATUS AND METHOD FOR IMAGING BLOOD IN A TARGET REGION OF TISSUE

This disclosure relates to apparatus for imaging blood within a target region of tissue and a corresponding method of imaging blood within a target region of tissue.

Wound healing is natural process performed by the human body in response to injury. The amount of time taken for a wound to heal is dependent on many different factors which include the human body's ability to heal itself and any treatments that are applied to the wound to accelerate wound healing. Understanding the healing status of a wound and being able to monitor the healing process helps to inform decisions on further treatment of the wound and can also assist in the development of future wound therapies.

One factor that is known to be associated with wound healing is the amount of blood supplied to blood vessels within tissue at or near a wound. The process of supplying blood to blood vessels within tissue is known as blood perfusion. Oxygen and nutrients carried by blood within wounded tissue are essential for wound healing and so the amount of oxygenated blood within tissue is known to correlate well with wound healing. Conventional techniques for determining the presence of blood within skin tissue include near-infrared imaging to determine oxygen saturation of blood vessels within tissue at or near a wound. Typically, such techniques require specialised equipment that is both bulky and expensive. Techniques for imaging blood within tissue can be hampered by reflection of illuminating light by the upper surface of the tissue. It is an aim of the present disclosure to at least partly mitigate the above-mentioned problems.

It is an aim of certain embodiments of the present disclosure to provide a means for imaging blood within tissue that can utilise a light source that provides illumination using visible light having a broad spectral range.

It is an aim of certain embodiments of the present disclosure to mitigate the effect of illuminating light which does not penetrate tissue on images obtained of blood within the tissue.

It is an aim of certain embodiments of the present disclosure to provide a means for imaging blood within tissue such that blood perfusion within the tissue can be assessed. - -

According to some embodiments, there is provided apparatus for imaging blood within a target region of tissue, comprising: an imaging device configured to output image data associated with light received by the imaging device having a first spectral range and configured to output image data associated with light received by the imaging device having a second spectral range, wherein the absorptivity by blood of light having the first spectral range is less than the absorptivity by blood of light having the second spectral range; and a controller or controlling element configured to capture the image data associated with light received by the imaging device having the first spectral range and image data associated with light received by the imaging device having the second spectral range contemporaneously and to process the captured image data associated with light having the first spectral range and the captured image data associated with light having the second spectral range to generate compound image data associated with an amount of blood within the target region of tissue.

The imaging device may comprise an imaging sensor comprising a plurality of sensor elements, wherein each sensing element is configured to output data associated with the amount of light received by the sensing element at the first spectral range and to output data associated with the amount of light received by the sensing element at the second spectral range.

The plurality of sensor elements may be arranged in a two-dimensional array. The imaging sensor may comprise a digital imaging sensor. The digital imaging sensor may comprise a complementary metal-oxide semiconductor image sensor or a charge-couple device imaging sensor.

The controlling element may be configured to record a first value associated with the amount of light received by each sensing element at the first spectral range and a second value associated with the amount of light received by each sensing element at the second spectral range.

The controlling element may be further configured to generate a compound value associated with each sensing element based on the first value and the second value. The compound value may be a difference between the first value and the second value. The controlling element may be configured to apply a scaling factor to the first value and/or second value when generating the compound value. . .

The apparatus may further comprise a digital display unit, wherein the controlling element is configured to display a digital image comprising a plurality of pixels on the display, wherein each pixel is associated with at least one of the sensing elements and each pixel has a value based on the compound value associated with each respective sensing element.

The digital image may have a predefined brightness and/or colour scale based on which the compound values for each sensing element are represented. The first spectral range may correspond to a spectral range associated with red light. The second spectral range may correspond to a spectral range associated with green light.

The apparatus may further comprise a light source configured to provide illuminating light having the first spectral range and to provide illuminating light having the second spectral range.

The light source may be configured to provide illuminating light having a spectral range which encompasses the first spectral range and the second spectral range. The light source may comprise at least one light emitting diode.

According to some embodiments, there is provided a method of imaging blood within a target region of tissue comprising the steps of: capturing image data associated with at least a portion of a target region of tissue at a first spectral range; capturing image data associated with at least the portion of a target region of tissue at a second spectral range, wherein the absorptivity by blood of light having the first spectral range is less than the absorptivity by blood of light having the second spectral range, wherein the image data associated with at least a portion of a target region of tissue at a first spectral range and the image data associated with at least the portion of a target region of tissue at a second spectral range are captured contemporaneously; and processing the image data captured at the first spectral range and the image data captured at the second spectral range to generate compound image data associated with an amount of blood within the target tissue.

The step of capturing image data at the first spectral range and the step of capturing image data at the second spectral range may comprise capturing image data using an imaging sensor comprising a plurality of sensor elements to capture image data associated with the amount of light received by each sensing element at each of the first spectral range and the second spectral range.

The step of processing the image data captured at the first spectral range and the image data captured at the second spectral range may comprise the step of comparing a first value associated with the amount of light received by each sensing element at the first spectral range and a second value associated with the amount of light received by each sensing element at the second spectral range. The step of processing the image data captured at the first spectral range and the image data captured at the second spectral range may comprise the step of generating a compound value associated with each sensing element based on the first value and the second value. The compound value may be a difference between the first value and the second value.

The method may further comprise the step of applying a scaling factor to the first value and/or second value when generating the compound value.

The method may further comprise the step of at least one of displaying, storing and transmitting the compound image data for analysis.

The method may further comprise the step of generating digital image having a predefined brightness and/or colour scale based on which the compound values for each sensing element are represented.

The first spectral range may correspond to a spectral range associated with red light. The second spectral range may correspond to a spectral range associated with green light.

The method may further comprise the step of illuminating the target region of tissue using a light source which provides illuminating light having first spectral range and the second spectral range. The illuminating light may have a spectral range which encompasses the first spectral range and the second spectral range. The light source may comprise at least one light emitting diode. Certain embodiments of the present disclosure allow for images to be obtained of a target region of tissue that provide an indication of the amount and/or distribution and/or - - concentration of blood within the skin tissue. Certain embodiments of the present disclosure allow for images to be obtained using digital imaging sensors.

Certain embodiments of the present disclosure allow for images to be obtained using digital imaging sensors configured to produce image data having at least two components associated with different spectral ranges.

Certain embodiments of the present disclosure allow for images to be generated by combining image data having at least two components associated with different spectra ranges.

According to some embodiments, there is provided apparatus for imaging blood within a target region of tissue, comprising: an imaging device configured to output image data associated with light received by the imaging device having a first spectral range and configured to output image data associated with light received by the imaging device having a second spectral range, wherein the absorptivity by blood of light having the first spectral range is less than the absorptivity by blood of light having the second spectral range; and a controller or controlling element configured to capture the image data associated with light received by the imaging device having the first spectral range and image data associated with light received by the imaging device having the second spectral range contemporaneously and to process the captured image data associated with light having the first spectral range and the captured image data associated with light having the second spectral range to generate compound image data associated with an amount of blood within the target region of tissue, wherein the first spectral range corresponds to a spectral range associated with red light.

According to some embodiments, there is provided apparatus for imaging blood within a target region of tissue, comprising: a light source configured to provide illuminating light having a first spectral range and to provide illuminating light having a second spectral range; an imaging device configured to output image data associated with light received by the imaging device having the first spectral range and configured to output image data associated with light received by the imaging device having the second spectral range, wherein the absorptivity by blood of light having the first spectral range is less than the absorptivity by blood of light having the second spectral range; and a controller or controlling element configured to capture the image data associated with light received by the imaging device having the first spectral range and image data associated with light received by the - - imaging device having the second spectral range contemporaneously and to process the captured image data associated with light having the first spectral range and the captured image data associated with light having the second spectral range to generate compound image data associated with an amount of blood within the target region of tissue.

According to some embodiments, there is provided a method of imaging blood within a target region of tissue comprising the steps of: capturing image data associated with at least a portion of a target region of tissue at a first spectral range; capturing image data associated with at least the portion of a target region of tissue at a second spectral range, wherein the absorptivity by blood of light having the first spectral range is less than the absorptivity by blood of light having the second spectral range, wherein the image data associated with at least a portion of a target region of tissue at a first spectral range and the image data associated with at least the portion of a target region of tissue at a second spectral range are captured contemporaneously; and processing the image data captured at the first spectral range and the image data captured at the second spectral range to generate compound image data associated with an amount of blood within the target tissue, wherein the second spectral range corresponds to a spectral range associated with green light. According to some embodiments, there is provided a method of imaging blood within a target region of tissue comprising the steps of: illuminating a target region of tissue using a light source which provides illuminating light having a first spectral range and a second spectral range, wherein the illuminating light has a spectral range which encompasses the first spectral range and the second spectral range; capturing image data associated with at least a portion of a target region of tissue at the first spectral range; capturing image data associated with at least the portion of a target region of tissue at the second spectral range, wherein the absorptivity by blood of light having the first spectral range is less than the absorptivity by blood of light having the second spectral range, wherein the image data associated with at least a portion of a target region of tissue at a first spectral range and the image data associated with at least the portion of a target region of tissue at a second spectral range are captured contemporaneously; and processing the image data captured at the first spectral range and the image data captured at the second spectral range to generate compound image data associated with an amount of blood within the target tissue. According to some embodiments, there is provided apparatus for imaging blood within a target region of tissue, comprising: a light source configured to illuminate at least a portion of a target region of tissue with linearly polarised light having at least a first spectral range and a second spectral range, wherein the absorptivity by blood of light having the first spectral range is less than the absorptivity by blood of light having the second spectral range; an imaging system having an imaging sensor configured to capture an image of at least a portion of the target region of tissue illuminated by the linearly polarised light; and a first linearly polarising filter arranged in front of the imaging device such that, in use, the polarising filter is disposed between the imaging device and the target region of tissue, wherein the first linearly polarising filter is arranged to block polarised illuminating light reflected by the target region of tissue.

The first linearly polarising filter may be arranged to polarise light in a plane which is orthogonal to the plane of polarisation of the illuminating light.

The light source may comprise a light emitter configured to emit unpolarised light and a second linearly polarising filter disposed in front of the light emitter. The light emitter may comprise at least one light emitting diode.

The second linearly polarising filter may be arranged in a cross-polarised configuration with respect to the first polarising filter such that light polarised by the second linearly polarising filter which remains polarised after being reflected by the target region of skin tissue is blocked by the first linearly polarising filter.

The first and second linearly polarising filters may be arranged such that the plane of polarisation of the first linearly polarising filter is at an angle of 90 degrees to the plane of polarisation of the second linearly polarising filter. The light source may be configured to illuminate the portion of the target region of tissue with visible light.

The first spectral range may correspond to a spectral range associated with red light and the second spectral range corresponds to a spectral range associated with green light.

The light source may comprise a diffuser arranged to provide diffused illuminating light.

The apparatus may be a smartphone. According to some embodiments, there is provided a method of imaging blood within a target region of tissue, comprising the steps: illuminating a target region of tissue using - - linearly polarised light having at least a first spectral range and a second spectral range, such that the linearly polarised light is scattered and/or reflected by the target region of tissue, wherein the absorptivity by blood of light having the first spectral range is less than the absorptivity by blood of light having the second spectral range; arranging an imaging system comprising an imaging sensor such that the imaging sensor is arranged to receive light scattered and/or reflected by the target region of tissue; disposing a linearly polarising filter between the target region of tissue and the imaging sensor such that scattered light which has been depolarised by the target region of tissue is transmitted by the linearly polarising filter and reflected light which remains polarised is blocked by the linearly polarising filter; and using the imaging system to capture at least one image of at least a portion of the target region of tissue using light which has been transmitted by the linearly polarising filter.

The linearly polarising filter may be arranged such that the plane of polarisation of the linearly polarising filter is orthogonal to the plane of polarisation of the illuminating light.

The step of illuminating a target region of tissue using linearly polarised light may comprise the step of using a light emitter configured to emit unpolarised light to emit light and disposing a second linearly polarising filter in front of the emitter to polarise the illuminating light. The target region of tissue may be illuminated with visible light.

The visible light may comprise a first spectral range that corresponds to a spectral range associated with red light and a second spectral range that corresponds to a spectral range associated with green light. The linearly polarised light may be diffused light.

According to some embodiments, there is provided a method of imaging blood within a target region of tissue, comprising the steps: illuminating a target region of tissue using linearly polarised light having at least a first spectral range and a second spectral range, such that the linearly polarised light is scattered and/or reflected by the target region of tissue, wherein the absorptivity by blood of light having the first spectral range is less than the absorptivity by blood of light having the second spectral range; transmitting by a linearly polarising filter disposed between the target region of tissue and the imaging sensor scattered light which has been depolarised by the target region of tissue and blocking by the linearly polarising filter reflected light which remains polarised; receiving with an imaging sensor light scattered and/or reflected by the target region of tissue; and capturing at least one image of at least a - - portion of the target region of tissue using light which has been transmitted by the linearly polarising filter.

The visible light may comprise a first spectral range that corresponds to a spectral range associated with red light and a second spectral range that corresponds to a spectral range associated with green light. The linearly polarised light may be diffused light. Certain embodiments of the present disclosure allow for images of blood within tissue to be obtained that are not adversely affected by light which is reflected by the tissue without penetrating the tissue.

Embodiments of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings in which:

Figure 1 shows an imaging apparatus for imaging a target region of tissue;

Figure 2 is a schematic representation of key components of the imaging apparatus shown in Figure 1 ;

Figure 3 is a graphical illustration of spectral response curves for a sensor used in the apparatus shown in Figure 1 ; Figure 4 is a flow chart of a method of imaging a target region of tissue using the apparatus shown in Figure 1 ;

Figure 5 is graphical illustration showing absorptivity of light by haemoglobin for different wavelengths; - -

Figure 6A is an illustrative example of an image generated by the apparatus shown in Figure 1 ;

Figure 6B is an illustrative example of a further image generated by the apparatus shown in Figure 1 ;

Figure 7 is a flow chart of further method of imaging a target region of tissue using the apparatus shown in Figure 1 ; Figure 8A is an illustrative example of an image generated by the method shown in Figure 7;

Figure 8B is an illustrative example of a further image method generated by the method shown in Figure 7; Figure 9 is a flow chart of a further method of imaging a target region of tissue using the apparatus shown in Figure 1 ;

Figure 10A is an illustrative example of an image generated using the method shown in Figure 9;

Figure 10B is an illustrative example of an image generated using the method shown in Figure 9;

Figure 10C is an illustrative example of an image generated using the method shown in Figure 9;

Figure 1 1 is a schematic presentation of apparatus for imaging a target region of skin tissue; and Figure 12 is presentation of another apparatus for imaging a target region of skin tissue.

Figure 1 shows an apparatus 2 for imaging blood vessels within a target region of tissue being used to investigate distribution of blood within tissue at the back of a portion of a person's hand 7. The apparatus 2 could, of course, be used to image other regions of a person's body or portions of an animal's body such as a region of a torso or a leg or an arm, for example. - -

The apparatus 2 comprises a support structure in the form of a support frame 4 having a base 6 on which the hand 7 is placed, walls 8, 10 which extend upwardly from the base 6 and an equipment support platform 12. The support platform 12 extends horizontally from one wall 8 to the other wall 10 and is located above the base 6 and spaced away from the base 6 by a suitable distance. In the embodiment shown, the support platform 12 is spaced from the base 6 by 30cm. The support platform 12 may be spaced from the base 6 by between 5cm and 100cm, such as between 20cm and 50cm in accordance with requirements such as a requirement to keep a target region of tissue within a focal range of a camera module, as described below.

A light source 14 is secured to the support platform 12 and arranged to illuminate the back of the hand 7 placed on the base 6 below. A camera module 16 is also secured to the support platform 12 and arranged to capture images of the back of the hand 7 placed on the base 6 below. The support frame 4 therefore holds the light source 14 and the camera module 16 in a fixed special relationship with respect to each other and the base 6. A display unit 18 for processing and displaying images captured by the camera module 16 is secured to the support platform 12. In the embodiment show, the display unit 18 comprises a portable device having an integrated screen 20. The display unit 18 may be a tablet device, smart phone, laptop, computer or the like.

Figure 2 is a schematic representation of components of the apparatus 2 shown in Figure 1 . Components of the display unit 18 are enclosed by broken lines. The display unit 18 comprises a power source in the form of a battery 22, a controller or processor 24 and an output device 26 which is configured to display an output from the processor 24 on the screen 20 of the display unit 8. The processor 24 is configured to control the light source 14 and to process image data from the camera module 16. In other embodiments, other power sources may be used such as a mains power supply or the like. In the embodiment shown, the light source 14 is a high-intensity light source in the form of an LED torch. The LED torch comprises a plurality of LEDs 15 which are configured to emit white light having a broad spectral range. For example, each LED may be configured to emit light having spectral range of wavelengths between 380nm and 770nm. The camera module 16 comprises a digital imaging sensor 17 having a two-dimensional array of discrete sensing elements. Each sensing element is configured to produce an - - output having three separate components including: a component associated with the amount of red light received at the sensing element; a component associated with the amount of green light received at the sensing element; and a component associated with the amount of blue light received at the sensing element.

In the embodiment shown, each sensing element comprises three separate identical sensors. Each sensing element has a respective filter configured to transmit light within a predefined spectral range associated with one of red, green and blue light respectively. Such digital imaging sensors are commonly used in the field of digital photography. In the embodiment shown, the digital imaging sensor is a complementary metal-oxide semiconductor (CMOS) digital imaging sensor. The sensor is a Sony™ IMX219 sensor configured to produce image data for generating a 3296 by 2512 pixel image. The spectral response curves for each of the component outputs of the digital imaging sensor 17 is shown in Figure 3.

The spectral response curve associated with the amount of blue light received at each sensing element is shown by response curve B. The response curve has a peak response for blue light within the spectral range 400nm and 500nm. The spectral response curve associated with the amount of green light received at each sensing element is shown by response curve G. The response curve has a peak response for green light within the spectral range 520nm and 580nm. The spectral response curve associated with the amount of red light received at the sensing element is shown by response curve R. The response curve has a peak response for red light within the spectral range 590nm and 750nm.

The imaging sensor 17 is therefore configured to produce output components associated with the amount of blue, green and red light received at each sensing element which can be processed to generate an image comprising an array of pixels in which each pixel is associated with a respective sensor element. Images can therefore be produced in which each pixel has a blue, green or red value that corresponds to the amount of blue, green and red light received at each sensing element. Other sensors having suitable response curves such as a charge coupled devices (CCD) or the like could of course be utilised. A flow chart illustrating a method of imaging blood within a target region of tissue in order to determine the distribution of blood within the tissue is shown in Figure 4. - -

At step S1010, a hand 7 is placed with the palm facing upward on the base 6 of the support frame 4 below the light source 14 and the camera module 16. At step S1020, the light source 14 is activated by the processor 24 to illuminate the region of the hand 7 in view of the camera module 16. While the hand is illuminated, the camera module 16 is controlled by the processor 24 to produce image data associated with a target region of tissue of the hand 7 which is within view of the camera module 16 and illuminated by the light source 14. In particular, the digital imaging sensor 17 of the camera module 16 is controlled to produce image data for each of the sensing elements forming the array of sensing elements. The image data for each sensing element has blue, green and red components, as described above.

At step S1030, the processor 24 determines a value for each of the blue, green and red components based on the received image data. In particular, the processor 24 generates a red value IR and a green value IG and a blue value IB for each sensing element. The red value IR is associated with the amount of red light received by the sensing element. The green value IG is associated with the amount of green light received by the same sensing element. The blue value IB is associated with the amount of blue light received by the same sensing element. The values are then used to generate a visual digital image and a compound digital image of the target region of tissue. The step of generating a visual digital image is optional. Each image comprises an array of pixels in which the location of each pixel corresponds to the location of a corresponding sensing element of the imaging sensor 17.

The processor 24 generates the visual digital image, as shown in Figure 6A, using all three components to produce an image corresponding to that which is seen by the naked eye. The image is displayed on the screen 20 of the display unit 18 by the output device 26. The first image allows the target region of tissue to be inspected by a clinician to determine that the hand 7 is positioned correctly and that there are no anomalies that may affect analysis.

In order to generate the compound digital image, the processor 24 generates a compound value lc for each sensing element which corresponds to a respective pixel of the compound digital image. - -

A compound value Ic for each pixel is generated by subtracting the green value IG from the red value IR. In order to compensate for differences in the amount of red and green light that is emitted by the light source 14, or to compensate for differences in the sensitivity of the imaging sensor 17 to red and green light, a scaling factor 'a' is applied to the green value IG. The value of 'a' may also set in accordance with other subjective factors related to representation and interpretation of the second image. The value of 'a' may be in the range 0.01 to 100, such as in the range 0.1 to 10 and may be in the range 1 to 5, such as 1. The compound value Ic is therefore calculated as follows:

The magnitude of the compound value Ic provides an indication of the local distribution of blood within the target region of tissue associated with the pixel. This is because haemoglobin within blood absorbs green light much better than red light and so the amount of green light received at a sensing element is heavily dependent on the amount of blood within skin tissue whereas the amount of red light received at a sensing element is not.

To aid further explanation, Figure 5 shows the spectral absorption by haemoglobin and haemoglobin species of light having wavelengths between 450nm and 750nm (as described at http://www.derangedphysiology.com/main/core-topics-intensive-care/arterial-blood-gas- interpretation/Chapter%203.0.1/absorption-spectroscopy-haemoglobin-species, which is incorporated herein by reference in its entirety).

Compared against the spectral response curves shown in Figure 3, it can be seen that haemoglobin and the species oxygenated haemoglobin absorb more green light corresponding to the spectral range of the response curve G than they absorb red light corresponding to the spectral range of the response curve R. Consequently, the amount of green light absorbed at the target region of tissue is highly dependent on the amount of blood within the tissue. Conversely, the amount of red light absorbed at the target region of tissue has a much lower dependency on the amount of blood within the tissue.

The approximate ranges of the response curves G and R are superimposed on Figure 5 as GR and RR, respectively. Although there is some overlap of the ranges GR and RR, it will be appreciated that overall proportion of green light absorbed by the haemoglobin within the tissue will be greater than the proportion of red light absorbed. - -

The green value IG for each pixel is proportional to the amount of green light detected by the imaging sensor 1 7 and so is inversely proportional to the amount of light absorbed. Therefore, a low green value IG, and by implication a high compound value lc, is associated with a large amount of blood within the region of tissue. The compound value lc therefore provides a reliable indicator of the amount of blood within tissue depicted by an associated pixel in the compound image.

In contrast, the skin tissue itself absorbs green and red light having spectral ranges corresponding to those shown in Figure 3 substantially equally and so the value of lc is relatively unaffected by the nature of the skin tissue surrounding blood vessels.

In the embodiment shown, the compound value lc is converted for each pixel using a suitable scale, for example, based on brightness and/or a colour range to produce the second image, as shown in Figure 6B. Areas having a greater amount (higher concentration) of blood within the tissue (i.e. comprising pixels having a relatively high IC-HIGH value) and areas having a lesser amount (lower concentration) of blood within the tissue (i.e. comprising pixels having a relatively low IC-LOW value) are delineated by contour lines within the image. Although spectral ranges associated with high and low amounts of absorptivity by haemoglobin and oxygenated haemoglobin are utilised in the present embodiment to evaluate the concentration of blood within tissue, other spectral ranges could be selected in addition to, or as an alternative, that correspond to high and low amounts of absorptivity for other compounds that may be found within tissue and other compounds that may be found within blood.

It will be appreciated that, in the present embodiment, the light source 14 is configured to emit light having at least one wavelength, or range of wavelengths, which is both well absorbed by blood and which falls within the range of the response curve of the imaging sensor 1 7 associated with green light and at least one wavelength, or range of wavelengths, which is less well absorbed by blood and which falls within the range of the response curve of the imaging sensor 1 7 associated with red light.

Figure 7 shows a flow chart illustrating a further method of using the apparatus 2 shown in Figure 1 to monitor changes in blood perfusion within skin tissue. The apparatus 2 is used in conjunction with a restriction device in the form of an inflatable cuff (not shown) such as - - an Omron M3 Comfort Automatic Upper Arm Blood Pressure Monitor. In this example, the inflatable cuff is wrapped around a person's upper arm of the hand that is to be inspected.

At step S2010, a hand is placed on the base 6 of the apparatus 2. At step S2020, the light source 14 is activated to illuminate a target region of tissue of the hand. At step 2030, a first compound image is generated using components of the output of the camera module 16 as described above in connection with the process step S1030. A visual image may also be generated, as described in step S1030. However, such a step is optional and omitted in this instance. At step S2040, a first compound image is stored, transmitted or displayed on the integrated display unit 18. Figure 8A shows a first compound image in which the hand is relatively well perfused. In this image, a scale having bands lco, lei , Ic2, Ic3, Ic4 for different lc values is used to distinguish between areas having lowest lc values lco (i.e. low blood concentration) and areas having highest lc values Ic4 (i.e. high blood concentration). Areas in which high and low concentrations of blood are present are therefore easy to identify within the image.

At step 2050, the inflatable cuff is inflated in order to restrict blood flow to the target region of tissue. After a suitable period of time has elapsed in which it can be expected that the restriction has reduced blood flow within the target region of tissue, the target region is illuminated again at step S2060, image data is captured by the camera module 16 and a second compound image is generated at step S2070. The suitable period of time may be at least 1 second or at least 2 seconds or at least 5 seconds. The light source 14 may be deactivated between capture of the first and second compound images or else remain activated throughout steps S2020 to S2060.

Figure 8B shows a second compound image in which the hand 7 is poorly perfused following restriction by the inflatable cuff. There are, therefore, relatively few areas of the image in which indicate that high concentrations of blood are present in the target region of tissue. The highest compound value lc in this image is Ic2 compared with Ic4 in the first image which indicates that much lower concentrations of blood are present.

Comparison of first and second compound images, for example by a clinician, enables a qualitative assessment of blood perfusion to the target region of tissue. For example, if the inflation pressure of the cuff is known, the amount of blood perfusion in the second compound image in comparison the first compound image may be used to determine whether blood flow to the tissue is within normal bounds. - -

In further embodiments, restriction of blood flow to the target region of tissue may be done by a tourniquet or pressing against a vessel supplying blood to the tissue or by pressing against the target region of tissue itself.

Figure 9 shows a variation of the method shown in Figure 7.

At steps S3010 to S3050, which are the same as steps S2010 to S2050, a first compound image of a target region of tissue is obtained. An example of a first compound image is shown in Figure 10A.

At step S3060, the target region of tissue is illuminated and image data is captured such that at step S3070, at least two consecutive compound images of the target region of tissue are captured after the cuff has been inflated. The consecutive images are stored, displayed or transmitted at step S3080 for analysis. At step S3090, the consecutive images are compared to determine whether the flow of blood within the target region has stabilised. The consecutive images may be compared visually by a clinician or automatically using image analysis software. If blood flow has not stabilised, steps S3060 to S3090 are repeated until it is determined that flow of blood within the target region of tissue is stable. An example of a compound image of the target region of tissue after it has been determined that the flow of blood within the tissue has stabilise is shown in Figure 10B.

At step S3100, the time ti at which blood flow has stabilised is recorded and the restriction removed immediately at step S31 10 by deflation of the cuff. Steps S3120 to S3140 (which correspond to steps S3020 to S3040) are then followed to obtain a further compound image of the target region of tissue. At step S3150, the further compound image is compared against the first compound image to determine whether the distribution of blood within the tissue at the target region, and hence the flow of blood within the tissue, has returned/recovered to the original state prior to restriction of the blood flow. The comparison may once again be made visually by a clinician or automatically using suitable image analysis software. If distribution of blood has not returned to the original state, steps S3120 to S3150 are repeated. Once it is determined that the distribution of blood has returned, or has substantially returned, to its original state, the time t.2 at which it does so is recorded. An example of a compound image obtained showing the distribution of blood within the target region of tissue once it has returned to its original state is shown in Figure 10C. - -

It will be appreciated that small movements of the tissue, hysteresis within the tissue and other variations will make it unlikely that blood flow within the tissue will return to the original state exactly. Therefore, suitable parameters may be used such as a proportion of the pixels of the compound image having a compound value Ic which is within a predetermined percentage of the first compound image or a return to an average Ic value for a selection of pixels of the image may be sufficient to determine that the distribution of blood has returned to the original state. The difference between time t.2 and time ti can then be calculated to determine a recovery time t.R that provides an indication of the quality of blood perfusion at the target region.

A variant of the method shown in Figure 9 has steps S3060 to S3100 omitted. Instead, a predetermined period of time is allowed to lapsed after inflation of the cuff which is sufficient to assume that blood flow has stabilised. The target region can then be imaged once the blood flow is known to have stabilised.

Figure 1 1 shows a variation of the apparatus shown in Figure 1 further comprising first and second linear polarising filters 28, 30. The first linear polarising filter 28 mounted in front of the camera module 16 and the second linear polarising filter 30 is mounted in front of the light source 14 so that light emitted by the light source 14 is polarised before reaching the target region of tissue of the hand 7 and light reflected by the tissue towards the camera module 16 is polarised before it reaches the camera module 16.

The first and second linear polarising filters are 28, 30 are arranged in a cross-polarised configuration so that light polarised by the second linear polarising filter 30 which has not been de-polarised before reaching the first linear polarising filter 28 will be blocked by the first linear polarising filter 28 and so prevented from reaching the imaging sensor 17 in the camera module 16. The polarising plane of the first linear polarising filter 28 is at 90 degrees to the polarising plane of the second linear polarising filter 30. The first and second linear polarising filters 28, 30 are set up in a cross-polarised configuration by placing a piece of flat aluminium foil (not shown) on the base 6 in the region at which the hand 7 is placed. The light source 14 is then used to illuminate the aluminium foil and images are captured of the illuminated portion of the aluminium foil. The first linear polarising filter 28 is then rotated with respect to the second linear polarising filter 30 until the light intensity of the captured images is at a minimum. At this orientation, the two polarising filters 28, 30 are considered to be in a cross-polarised configuration. - -

Only light T transmitted by the light source 14 and polarised by the second polarising filter 30 which is subsequently depolarised by the target region of tissue, for example on account of scattering events within the tissue, passes through the first linear polarising filter 28 to the camera module 16. Consequently, only light Rs which has penetrated the epidermis 7a of the skin tissue which undergoes multiple scattering events, and so has had an increased likelihood of being absorbed by blood vessels within the skin tissue, is used to generate an image of the target region. Light R which has been reflected without penetrating the skin tissue, and so which would provide an unreliable indication of the amount of blood within the skin tissue is prevented from reaching the camera module 16. The embodiment, when used to capture images using the methods outlined above, improves the quality and reliability of the images generated.

In some embodiments, a dedicated light source may be unnecessary since ambient light may be sufficient.

Camera modules comprising CCD or CMOS imaging sensors have been described with respect to the embodiments above. Other imaging sensors may be used that are suitable for detecting the spectral content of light and producing a digital image comprising a plurality of pixels in which each pixel can have a value that corresponds a spectral content of light received by the sensor at a corresponding portion of the sensor. Other imaging sensors having other suitable response curves may also be used.

Image data or images generated using image data can be processed or post-processed to enhance features of interest. For example, the brightness of images can be adjusted or contrast enhanced or colour adjusted or noise filter techniques or the like can be applied. Other imaging processing techniques may be used to highlight features of interest within the images.

Various light sources can be used for illumination. Light emitting diodes or a single diode may be used in accordance with the embodiments described above. Surface mounted diodes, which are compact, widely available, inexpensive, reliable, produce high-intensity light, have lower power consumption and are easy to integrate, may be used. Other light sources such as lasers, laser diodes, digital light projectors (DLPs), organic light emitting diodes (OLED) or incandescent light sources or the like may be used. The light source may be a broad-band or white light source such as the light source used in the embodiments described above, but may be a light source capable of illuminating the target region at two or - - more wavelengths, such as two monochromatic light sources, two laser diodes of different wavelengths, a multi-coloured LED or the like. Two light sources may be used, neither of which has an emission spectra extending over a region of overlap of response curves for the imaging sensor in which there is a significant response for each response curve. In an arrangement which comprises two light sources, the spectral range of one light source may be different from the spectral range of the other light source. For example, red and green LEDs could be used as respective light sources. An imaging sensor could be used which does not discriminate between the two spectral ranges and the light sources may be sequentially pulsed (i.e. activated and deactivated alternately) in order to obtain images at each of the respective spectral ranges. Diffuser of lens arrangements may be used to provide a reasonably uniform illumination across a region of interest or to focus light on particular areas of interest.

The light source, camera module and display unit may be incorporated into a portable hand- held device having a single housing in which the components are housed. For example, a hand-held digital camera unit having an integrated flash unit could be configured to generate images in accordance with the imaging methods described above.

In some embodiments, the portable hand-held device can be a smartphone, tablet, or the like with an integrated camera and a flash. For example, as illustrated in Figure 12, the hand-held device can be a smartphone 1200. The camera can be utilised to capture one or more images or videos. For instance, one or more images can be captured using standard, burst capture, such as IPHONE™ live photo capture. Capturing one or more images or videos can permit processing of the differential in absorption substantially in real time or offline.

One or more polarising filters (as described herein) can be positioned over the flash. The flash can be turned on for the duration of the image or video capture. An orthogonal polarising filter (whose polarising plane can be at 90 degrees to polarising plane(s) of the one or more filters positioned over the flash as described herein) can be positioned over an image lens of the camera. In some cases, the one or more filters positioned over the flash and the orthogonal filter positioned over the image lens are connected to be in cross- polarised configuration as described herein. The one or more filters positioned over the flash can be tinted to prioritise only the frequencies of interest as described herein. - -

Alternatively or additionally, a lens, such as macro lens 1210, can be used over the image lens of the camera. Alternatively or additionally, a separate illumination source can be used. In any of the embodiments described herein, Eulerian amplification techniques can be used in the analysis, as described in U.S. Provisional Patent Application Nos. 62/506,524, filed May 15, 2017 and 62/506,551 , filed May 15, 2017, each of which is incorporated herein by reference in its entirety. Eulerian magnification can, for example, amplify variations in absorption due to the pulse providing bursts of blood.

It will be appreciated that throughout this specification reference is made to a wound. It is to be understood that the term wound is to be broadly construed and encompasses open and closed wounds in which skin is torn, cut or punctured or where trauma causes a contusion, or any other superficial or other conditions or imperfections on the skin of a patient or otherwise that benefit from reduced pressure treatment. A wound is thus broadly defined as any damaged region of tissue where fluid may or may not be produced. Examples of such wounds include, but are not limited to, abdominal wounds or other large or incisional wounds, either as a result of surgery, trauma, sterniotomies, fasciotomies, or other conditions, dehisced wounds, acute wounds, chronic wounds, subacute and dehisced wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure ulcers, stoma, surgical wounds, trauma and venous ulcers or the like.

In the drawings like reference numerals refer to like parts.

Throughout the description and claims of this specification, the words "comprise" and "contain" and variations of them mean "including but not limited to" and they are not intended to (and do not) exclude other moieties, additives, components, integers or steps. Throughout the description and claims of this specification, the singular encompasses the plural unless the context otherwise requires. In particular, where the indefinite article is used, the specification is to be understood as contemplating plurality as well as singularity, unless the context requires otherwise.

Features, integers, characteristics or groups described in conjunction with a particular aspect, embodiment or example of the disclosure are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so - - disclosed, may be combined in any combination, except combinations where at least some of the features and/or steps are mutually exclusive. The disclosure is not restricted to any details of any foregoing embodiments. The disclosure extends to any novel one, or novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

The reader's attention is directed to all papers and documents which are filed concurrently with or previous to this specification in connection with this application and which are open to public inspection with this specification, and the contents of all such papers and documents are incorporated herein by reference in their entireties.

Claims

Apparatus for imaging blood within a target region of tissue, comprising:

an imaging device configured to output image data associated with light received by the imaging device having a first spectral range and configured to output image data associated with light received by the imaging device having a second spectral range, wherein the absorptivity by blood of light having the first spectral range is less than the absorptivity by blood of light having the second spectral range; and

a controlling element configured to capture the image data associated with light received by the imaging device having the first spectral range and image data associated with light received by the imaging device having the second spectral range contemporaneously and to process the captured image data associated with light having the first spectral range and the captured image data associated with light having the second spectral range to generate compound image data associated with an amount of blood within the target region of tissue.

The apparatus of claim 1 , wherein the imaging device comprises an imaging sensor comprising a plurality of sensor elements, wherein each sensing element is configured to output data associated with the amount of light received by the sensing element at the first spectral range and to output data associated with the amount of light received by the sensing element at the second spectral range.

The apparatus of claim 2, wherein the plurality of sensor elements are arranged in a two-dimensional array.

The apparatus of claim 2 or 3, wherein the imaging sensor comprises a digital imaging sensor.

The apparatus of claim 4, wherein the digital imaging sensor comprises a complementary metal-oxide semiconductor image sensor or a charge-couple device imaging sensor.

The apparatus of any one of claims 2 to 5, wherein the controlling element is configured to record a first value associated with the amount of light received by each sensing element at the first spectral range and a second value associated with the amount of light received by each sensing element at the second spectral range.

7. The apparatus of claim 6, wherein the controlling element is further configured to generate a compound value associated with each sensing element based on the first value and the second value.

8. The apparatus of claim 7, wherein the compound value is a difference between the first value and the second value.

9. The apparatus of claim 7 or 8, wherein the controlling element is configured to apply a scaling factor to the first value and/or second value when generating the compound value.

10. The apparatus of any one of claims 7 to 9, further comprising a digital display unit, wherein the controlling element is configured to display a digital image comprising a plurality of pixels on the display, wherein each pixel is associated with at least one of the sensing elements and each pixel has a value based on the compound value associated with each respective sensing element.

1 1 . The apparatus of claim 10, wherein the digital image has a predefined brightness and/or colour scale based on which the compound values for each sensing element are represented.

12. The apparatus of any one of the preceding claims, wherein the first spectral range corresponds to a spectral range associated with red light.

13. The apparatus of any one of the preceding claims, wherein the second spectral range corresponds to a spectral range associated with green light.

14. The apparatus of any one of the preceding claims, further comprising a light source configured to provide illuminating light having the first spectral range and to provide illuminating light having the second spectral range.

15. The apparatus of claim 14, wherein the light source is configured to provide illuminating light having a spectral range which encompasses the first spectral range and the second spectral range.

16. The apparatus of claim 14 or 15, wherein the light source comprises at least one light emitting diode.

17. A method of imaging blood within a target region of tissue comprising the steps of:

capturing image data associated with at least a portion of a target region of tissue at a first spectral range;

capturing image data associated with at least the portion of a target region of tissue at a second spectral range, wherein the absorptivity by blood of light having the first spectral range is less than the absorptivity by blood of light having the second spectral range, wherein the image data associated with at least a portion of a target region of tissue at a first spectral range and the image data associated with at least the portion of a target region of tissue at a second spectral range are captured contemporaneously; and

processing the image data captured at the first spectral range and the image data captured at the second spectral range to generate compound image data associated with an amount of blood within the target tissue.

18. The method of claim 17, wherein the step of capturing image data at the first spectral range and the step of capturing image data at the second spectral range comprise capturing image data using an imaging sensor comprising a plurality of sensor elements to capture image data associated with the amount of light received by each sensing element at each of the first spectral range and the second spectral range.

19. The method of claim 18, wherein the step of processing the image data captured at the first spectral range and the image data captured at the second spectral range comprises the step of comparing a first value associated with the amount of light received by each sensing element at the first spectral range and a second value associated with the amount of light received by each sensing element at the second spectral range.

20. The method of claim 19, wherein the step of processing the image data captured at the first spectral range and the image data captured at the second spectral range comprises the step of generating a compound value associated with each sensing element based on the first value and the second value.

21 . The method of claim 20, wherein the compound value is a difference between the first value and the second value.

22. The method of claim 20 or 21 , further comprising the step of applying a scaling factor to the first value and/or second value when generating the compound value.

23. The method of any one of claims 17 to 22, further comprising the step of at least one of displaying, storing and transmitting the compound image data for analysis.

24. The method of claim 23, comprising the step of generating digital image having a predefined brightness and/or colour scale based on which the compound values for each sensing element are represented.

25. The method of any one of claims 17 to 24, wherein the first spectral range corresponds to a spectral range associated with red light.

26. The method of any one of claims 17 to 25, wherein the second spectral range corresponds to a spectral range associated with green light.

27. The method of any one of claims 17 to 26, further comprising the step of illuminating the target region of tissue using a light source which provides illuminating light having first spectral range and the second spectral range.

28. The method of claim 27, wherein the illuminating light has a spectral range which encompasses the first spectral range and the second spectral range.

29. The method of claim 27 or 28, wherein the light source comprises at least one light emitting diode.

30. Apparatus for imaging blood within a target region of tissue, comprising:

an imaging device configured to output image data associated with light received by the imaging device having a first spectral range and configured to output image data associated with light received by the imaging device having a second spectral range, wherein the absorptivity by blood of light having the first spectral range is less than the absorptivity by blood of light having the second spectral range; and a controlling element configured to capture the image data associated with light received by the imaging device having the first spectral range and image data associated with light received by the imaging device having the second spectral range contemporaneously and to process the captured image data associated with light having the first spectral range and the captured image data associated with light having the second spectral range to generate compound image data associated with an amount of blood within the target region of tissue,

wherein the first spectral range corresponds to a spectral range associated with red light.

31 . Apparatus for imaging blood within a target region of tissue, comprising:

a light source configured to provide illuminating light having a first spectral range and to provide illuminating light having a second spectral range;

an imaging device configured to output image data associated with light received by the imaging device having the first spectral range and configured to output image data associated with light received by the imaging device having the second spectral range, wherein the absorptivity by blood of light having the first spectral range is less than the absorptivity by blood of light having the second spectral range; and

32. A method of imaging blood within a target region of tissue comprising the steps of:

processing the image data captured at the first spectral range and the image data captured at the second spectral range to generate compound image data associated with an amount of blood within the target tissue,

wherein the second spectral range corresponds to a spectral range associated with green light.

33. A method of imaging blood within a target region of tissue comprising the steps of:

illuminating a target region of tissue using a light source which provides illuminating light having a first spectral range and a second spectral range, wherein the illuminating light has a spectral range which encompasses the first spectral range and the second spectral range;

capturing image data associated with at least a portion of a target region of tissue at the first spectral range;

capturing image data associated with at least the portion of a target region of tissue at the second spectral range, wherein the absorptivity by blood of light having the first spectral range is less than the absorptivity by blood of light having the second spectral range, wherein the image data associated with at least a portion of a target region of tissue at a first spectral range and the image data associated with at least the portion of a target region of tissue at a second spectral range are captured contemporaneously; and

34. Apparatus for imaging blood within a target region of tissue, comprising:

a light source configured to illuminate at least a portion of a target region of tissue with linearly polarised light having at least a first spectral range and a second spectral range, wherein the absorptivity by blood of light having the first spectral range is less than the absorptivity by blood of light having the second spectral range; an imaging system having an imaging sensor configured to capture an image of at least a portion of the target region of tissue illuminated by the linearly polarised light; and a first linearly polarising filter arranged in front of the imaging device such that, in use, the polarising filter is disposed between the imaging device and the target region of tissue, wherein the first linearly polarising filter is arranged to block polarised illuminating light reflected by the target region of tissue.

35. The apparatus of claim 34, wherein the first linearly polarising filter is arranged to polarise light in a plane which is orthogonal to the plane of polarisation of the illuminating light.

36. The apparatus of claim 34 or 35, wherein the light source comprises a light emitter configured to emit unpolarised light and a second linearly polarising filter disposed in front of the light emitter.

37. The apparatus of claim 36, wherein the light emitter comprises at least one light emitting diode.

38. The apparatus of claim 36 or 37, wherein the second linearly polarising filter is arranged in a cross-polarised configuration with respect to the first polarising filter such that light polarised by the second linearly polarising filter which remains polarised after being reflected by the target region of skin tissue is blocked by the first linearly polarising filter.

39. The apparatus of claim 38, wherein the first and second linearly polarising filters are arranged such that the plane of polarisation of the first linearly polarising filter is at an angle of 90 degrees to the plane of polarisation of the second linearly polarising filter.

40. The apparatus of any one of claims 34 to 39, wherein the light source is configured to illuminate the portion of the target region of tissue with visible light.

41 . The apparatus of claim 40, wherein the first spectral range corresponds to a spectral range associated with red light and the second spectral range corresponds to a spectral range associated with green light.

42. The apparatus of any one of claims 34 to 41 , wherein the light source comprises a diffuser arranged to provide diffused illuminating light.

43. The apparatus of any one of claims 34 to 42, wherein the apparatus comprises a smartphone.

44. A method of imaging blood within a target region of tissue, comprising the steps:

illuminating a target region of tissue using linearly polarised light having at least a first spectral range and a second spectral range, such that the linearly polarised light is scattered and/or reflected by the target region of tissue, wherein the absorptivity by blood of light having the first spectral range is less than the absorptivity by blood of light having the second spectral range;

arranging an imaging system comprising an imaging sensor such that the imaging sensor is arranged to receive light scattered and/or reflected by the target region of tissue;

disposing a linearly polarising filter between the target region of tissue and the imaging sensor such that scattered light which has been depolarised by the target region of tissue is transmitted by the linearly polarising filter and reflected light which remains polarised is blocked by the linearly polarising filter; and

using the imaging system to capture at least one image of at least a portion of the target region of tissue using light which has been transmitted by the linearly polarising filter.

45. The method of claim 44, wherein the linearly polarising filter is arranged such that the plane of polarisation of the linearly polarising filter is orthogonal to the plane of polarisation of the illuminating light.

46. The method of claim 45, wherein the step of illuminating a target region of tissue using linearly polarised light comprises the step of using a light emitter configured to emit unpolarised light to emit light and disposing a second linearly polarising filter in front of the emitter to polarise the illuminating light.

47. The method of any one of claims 44 to 46, wherein the target region of tissue is illuminated with visible light.

48. The method of claim 47, wherein the visible light comprises a first spectral range that corresponds to a spectral range associated with red light and a second spectral range that corresponds to a spectral range associated with green light.

49. The method of any one of claims 44 to 48, wherein the linearly polarised light is diffused light.

50. A method of imaging blood within a target region of tissue, comprising the steps:

transmitting by a linearly polarising filter disposed between the target region of tissue and the imaging sensor scattered light which has been depolarised by the target region of tissue and blocking by the linearly polarising filter reflected light which remains polarised;

receiving with an imaging sensor light scattered and/or reflected by the target region of tissue; and

capturing at least one image of at least a portion of the target region of tissue using light which has been transmitted by the linearly polarising filter.

51 . The method of claim 50, wherein the linearly polarising filter is arranged such that the plane of polarisation of the linearly polarising filter is orthogonal to the plane of polarisation of the illuminating light.

52. The method of claim 51 , wherein the step of illuminating a target region of tissue using linearly polarised light comprises the step of using a light emitter configured to emit unpolarised light to emit light and disposing a second linearly polarising filter in front of the emitter to polarise the illuminating light.

53. The method of any one of claims 50 to 52, wherein the target region of tissue is illuminated with visible light.

54. The method of claim 53, wherein the visible light comprises a first spectral range that corresponds to a spectral range associated with red light and a second spectral range that corresponds to a spectral range associated with green light.

55. The method of any one of claims 50 to 54, wherein the linearly polarised light is diffused light.